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CytoSorbents Corporation (OTCBB: CTSO) 2013 Earnings and Operating Results Conference Call

Key Takeaway: Corporation (OTCBB: CTSO) 2013 Earnings and Operating Results March 31, 2014 @ 4:15 pm Eastern This official company transcript has been edited for clarity and does not differ materially from the actual conference call. Slide numbers have been inserted to allow readers to fo

Full Press Release Details

Corporation (OTCBB: CTSO)
2013 Earnings and Operating Results
March 31, 2014 @ 4:15 pm Eastern
This official company transcript has
been edited for clarity and does not differ materially from the actual conference call. Slide numbers have been inserted to allow
readers to follow along with the associated presentation.
Good day, ladies and gentlemen. Thank you
for standing by. Welcome to the CytoSorbents 2013 Shareholder Update Conference Call. During today's presentation, all parties
will be in a listen-only mode. This conference is being recorded today, March 31, 2014.
I would now like to turn the conference
over to our moderator, Ms. Donna Marincas. Please go ahead, Donna.
Donna Marincas - Moderator:
Thank you operator and good afternoon.
Welcome to CytoSorbents 2013 Operating and Financial Results Conference Call.
Slide 3: With us today are:
Slide 2: Before I turn the call
over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking
statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response
to your questions today. Therefore, the Company claims protection under Safe Harbor for forward-looking statements contained in
the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today and therefore, we
refer you to a more detailed discussion of these risks and uncertainties in the Company's filings with the SEC. Any projections
as to the Company's future performance represented by management include estimates today as of March 31, 2014 and the Company assumes
no obligation to update these projections in the future as market conditions change.
During today's conference call,
we will first have an overview presentation covering the financial and operational highlights for the quarter by Dr. Chan and
Ms. Bloch. We again have done our best to take everyone's submitted questions and will do our best to address
them in the presentation, but also in a Q&A session with management to follow. Thanks everyone again for participating. If
we do not answer your question, we would ask you to contact the Company directly after the call today.
At this time, I would like to turn the
call over to Dr. Phillip Chan. Please go ahead Dr. Chan.
Thanks very much Donna and welcome everyone
to our 2013 operating and financial results conference call. Thank you for taking the time to join the call today.
Since our last earnings report, there have
been a lot of developments and we definitely have new shareholders online today. What I'd like to do is go over a brief summary
of the company for the benefit of those new shareholders as well as for those who need an update of our story. Following that,
Kathy will give a brief overview of our financial and operating progress for the quarter as well as for 2013, and I will come back
on the line with an overview of the catalyst for 2014 that will help us drive growth for this year.
Slide 4: CytoSorbents is an
emerging leader in critical care immunotherapy. We are leading the prevention or treatment of life-threatening inflammation in
the intensive care unit. When we talk about immunotherapy, broadly taken, it is the ability to manipulate the immune response to
help fight disease. This is a $100 billion revenue market. This is not a total addressable market, this is not a potential theoretical
market. This is actually a market that has $100 billion in revenues from blockbuster products focused on manipulating the immune
Slide 5: Now we all know that in
order for the immune response to function normally, it has to be not too high and not too low. When the immune system is not functioning
well, people are at high risk of developing infection, cancer, as well as poor healing. And on the other end of the spectrum, when
the immune system is too high, patients are at high likelihood of developing things like allergy, asthma, anaphylaxis, autoimmune
diseases, severe inflammation such as sepsis and SIRS, and organ failure.
Companies have worked to try to counter
this by developing products, that when the immune system is too weak, will activate the immune response. Vaccines are an excellent
example of that. The five top companies in the vaccine space include Sanofi, Merck, GSK, Pfizer and Novartis, and together have
$26 billion in vaccine revenue alone - it is a $30+ billion category overall. And in the cancer immunotherapy space, $20 billion
in product revenues are generated every year with such blockbuster products such as Rituxan, Herceptin, Erbitux and others and
even cancer vaccine such as Provenge and other immunotherapies such as Yervoy from Bristol-Myers Squibb.
On the high end, when we're trying
to suppress the immune response, all of us have no doubt taken antihistamines for seasonal allergies, or steroids for other complications
of inflammation. Blockbuster products such as Zyrtec, Claritin, Allegra, and asthma medications such as Advair and Singulair produce
more than $20 billion in revenues every single year. And in the treatment of autoimmune diseases, blockbuster products such as
Enbrel from Amgen, Humira from AbbVie and Remicade from Johnson & Johnson, those three products alone have $26 billion in worldwide
revenue every year. And again, this is a $30+ billion revenue market overall.
But where CytoSorbents fits is really in
a space where we're almost by ourselves - this is in the critical care immunotherapy space where we're trying to reduce
the deadly inflammation that is leading to organ failure and death in patients with diseases like sepsis, burn injury, trauma and
many others. CytoSorb is a product that is approved in all 28 countries of the European Union, and is currently commercially
available in nine countries generating revenue, with 30+ post-market studies, the support of more than a 100 key opinion leaders,
and little-to-no competition.
Slide 6: So what is the $20 billion
critical care opportunity? Unfortunately many of us on the phone today know someone who has been admitted into the intensive care
unit for a life-threatening illness. In fact, millions of people are admitted to intensive care units every year in the U.S. and
in the European Union with deadly inflammation caused by inflammatory conditions such as sepsis, ARDS (acute respiratory distress
syndrome), burn injury, trauma, pancreatitis, influenza, and complications of surgery. In fact, in these conditions, little exists
to reduce inflammation and actively help patients get better. Rather, patients often need to be kept alive with machines called
"life support" things like mechanical ventilation and dialysis with the hope that their bodies heal
on their own over time. So without active therapies, patients linger in the ICU at cost of $2,000 to $3,000 a day in the United
States. Despite having some of the best medical treatment in the world, here in the United States still one in every three patients
often die in these life-threatening conditions. Because of this, and because of the lack of effective therapies to actively impact
outcome, the U.S. alone spends almost 1% of our gross domestic product, a staggering $80 - $90 billion on critical care medicine
Slide 7: So what is driving this
inflammation? Well, the inflammation is being driven by small proteins called cytokines that normally orchestrate the immune response,
and normally help stimulate and regulate the immune system to control inflammation. But cytokines are very much a dual-edged sword.
They are required for proper immune system function but when they are elevated they can actually cause or exacerbate
diseases such as autoimmune diseases.
Slide 8: But when they are in vast
excess, as is often found in patients with life-threatening conditions, it's often called "cytokine storm" and
that cytokine storm leads to massive uncontrolled inflammation that leads to the failure of vital organs, such as the lungs, the
brain, the heart, the kidneys, the liver and many other vital organs in the body. In fact, organ failure causes nearly half of
all deaths in the ICU today and little can be done to prevent or treat it.
Slide 9: So that is where we come
in. CytoSorb is specifically designed to remove the fuel to the fire of inflammation in the body. In fact, it represents one
of the newest and most powerful immunotherapies to control inflammation. It's approved in the European Union as the only
specifically approved cytokine filter and it is clinically proven to reduce key cytokines and cytokine storm by 30% to 50% in critically-ill
patients. It has a very broad indication for use, approved for use in any situation where cytokines are elevated, and it's
now been used safely in more than 1,500 human treatments with no serious device related adverse events.
Slide 10: The heart of our technology
is what you see here in this slide. It is a highly biocompatible, porous polymer bead roughly the size of grain of salt that acts
like a tiny sponge to remove harmful substances from blood and bodily fluids. The beads remove things based on size
as well as surface adsorption. These beads are protected by 32 issued U.S. patents and multiple applications pending and we manufacture
these beads from raw chemicals at our ISO 13485-certified facility in New Jersey. In fact these beads are one highest grade medical
sorbents on the medical market today.
Slide 11: So the goal of CytoSorb
is really to try to prevent or treat organ failure. When patients come into the ICU either from the emergency room or from the
Last updated: Mar 31, 2014